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Abstract:

A compact, self-contained apparatus for blood glucose testing, which
comprises a blood glucose meter (32), a lancet device (30), and an
enclosure for test media with separate compartments for new and used
disposable test media (28).

Claims:

1. An apparatus for blood glucose testing comprising: (a) a body having a
front and a back, (b) a meter unit, (c) a lancet device comprising a
trigger button for activating said lancet device, an arming slide for
arming said lancet device, and a depth control mechanism for setting a
lancet skin penetration depth (d) an enclosure for housing new test
media; and (e) an enclosure for housing soiled test media.

2. The apparatus as claimed in claim 1, which further comprises an
enclosure for housing medication to treat hypoglycemia and/or medication
to treat hyperglycemia.

3. (canceled)

4. The apparatus as in claim 1 or 2, wherein one or both of said
enclosures is a detachable cartridge.

5. The apparatus as in any of claims 1, 2, or 4, wherein said meter unit
is positioned parallel and adjacent to said lancet device.

6. The apparatus as in any of claims 1,2, or 4, wherein said meter unit
is positioned on top of said lancet device.

7. The apparatus as in any of claims 1-2 or 4-6, wherein said body
further comprises a detachable cover for providing access to said lancet
device for loading and unloading of lancets.

8. The apparatus as in any of claims 1-2 or 4-7, wherein said body
further comprises a sliding cover for providing access to said lancet
device for loading and unloading of lancets.

9. The apparatus as in any of claims 1-2 or 4-8, wherein said lancet
device is detachable from said meter unit and enclosure.

10. The apparatus as in any of claim 2 or 4-9, wherein said enclosure for
housing hypoglycemia and/or hyperglycemia treatment medication comprises
a horizontal area.

11. The apparatus as in any of claim 2 or 4-9, wherein said enclosure for
housing hypoglycemia and/or hyperglycemia treatment medication comprises
a vertical column area.

12. The apparatus as in any of the preceding claims, further comprising a
jacket to surround the outside of the apparatus.

[0003] An apparatus that combines essential blood glucose testing
equipment into a discreet self-contained unit, in order to provide a
transportable solution that simplifies the testing procedure and daily
use for a patient.

BACKGROUND OF THE INVENTION

[0004] The invention is based on widely available blood glucose test
meters and the method of use for determining the blood glucose
concentration with single-use disposable test strips adapted for
conducting diverse real-time or near real-time assays of analytes.

[0005] The invention further relates to a lancet device that arms and
releases a lancet needle used to puncture a user's skin and produce a
small blood sample for immediate testing.

[0006] Diabetics rely heavily on these machines and technology to monitor
and control blood glucose levels by receiving information that indicates
the need for medication or treatment. As a result, a diabetic patient
must regularly test his or her blood sugar multiple times per day in
order to make informed treatment decisions and remain healthy.

[0007] There are several components needed to perform this blood test
routine, which make the transport of all individual components
exceedingly difficult for frequent and immediate access. The only devices
currently available to patients combine all individual components into a
Zippered pouch or test kit, resulting in a bulky cumbersome package that
cannot be easily stored or transported in an individual's clothing
pocket. Inventions that have tried to address this issue such as
WO2005102154 or WO2001064105 have combined a test meter, lancet device,
and test strip storage, but have still not created an easily
transportable alternative that considers all the needs for on-the-go
blood glucose testing by a diabetic patient.

[0008] In addition, those inventions have also ignored the need for a
solution that is inconspicuous. Those inventions have created a pen-like
device and configuration for the combination of testing equipment,
perhaps focusing on ease of use for a care-provider rather than the needs
of the patient. In public settings, the foreignness of the obtrusive pen
like devices or the common, bulky test kit draw unnecessary attention to
the user who desires to perform his or her blood glucose test discreetly
and without explanation to others. Protecting the delicate psychological
nature of dealing with an incurable disease, such as Type I Juvenile
Diabetes, is improved when the equipment needed to manage the condition
resemble objects commonly found amongst all people, such as a rectangular
cell phones or other portable electronic devices. This situation is
especially relevant for teenagers and young adults who deal with
increased social pressure.

[0009] The currently available inventions have failed to include a storage
area to hold contaminated disposable test media, which is consistently
created after each blood test is completed. Used test media cannot be
stored with clean unused test strips. There are endless situations when a
public waste receptacle is not available, especially a waste receptacle
appropriate for receiving potential biohazard waste that contains human
blood. In order to provide a truly transportable, self-contained unit,
that allows blood glucose testing in any situation, a designated storage
compartment must be available to receive dirty test strips. The user can
later find a convenient waste receptacle to empty the dirty compartment
when it becomes full.

[0010] Another component that is not currently available is one that
addresses the additional need of diabetic patients to carry glucose
tablets in order to remedy the event of emergency hypoglycemic
situations. In these situations diabetics must treat their low blood
sugar by administering fast acting sources of concentrated high glucose,
preferably manufactured and widely available glucose tablets, which offer
a fast acting form of glucose provided in a uniform measurable dose.
Failure to treat a low blood sugar quickly and efficiently can create a
life threatening situation where a diabetic's brain becomes starved for
glucose and partially or completely shuts down, leading to cognitive
impairment, dangerous irrational behavior, coma, and death.

[0011] Detecting low blood sugar can occur naturally for some who feel
physical symptoms such as shakiness, headaches, dizziness, or blurred
vision; however, for the majority of diabetic patients, the only reliable
method for identifying these dangerous events is by utilizing a blood
glucose test meter to routinely test blood sugar levels. This is
especially true for patients that have had diabetes for several years and
no longer experience physical symptoms.

[0012] When a low blood sugar level is detected, the immediate next step
for a diabetic is to locate and orally administer glucose tablets. A
diabetic is advised to never be without a treatment for low blood sugar.
They are also advised to check their blood sugar before all serious
engagements, such as operating a motor vehicle, so that they will not
unexpectedly be caught in a low blood sugar episode producing irrational
behavior that could potentially endanger others.

[0013] For all these reasons and more, a superior solution to test blood
glucose levels in any location will also combine a way to treat low blood
sugars, eliminating the additional need of diabetic patients to carry
blood glucose tablets separately.

[0014] A similar situation can occur in reverse, when a diabetic
experiences hyperglycemia, or high blood sugar, and requires indication
from a blood glucose test meter followed by administration of an
appropriate treatment method. Fortunately, these events are generally
less urgent than hypoglycemia, however they can become emergency
situations if left unchecked or untreated. A common form of treatment for
hyperglycemia is injection of insulin, which requires the equipment of a
vial of insulin and a syringe. Another form of treatment is an orally
administered medication. A third form involves the use of an insulin pump
with which the user can program an insulin dose and have the pump perform
the delivery mechanically. A fourth form is using an insulin pen, which
allows easy transport of insulin and quick administration.

[0015] For patients that do not use an insulin pump or insulin pen,
carrying necessary insulin supplies or pills is an additional burden that
can be addressed by the invention that combines the ability to carry
these supplies with the blood glucose testing apparatus.

SUMMARY OF THE INVENTION

[0016] The present invention eliminates the bulk, inconvenience, and
discomfort of currently available devices by combining the necessary
components to store new test strips, draw blood samples, perform analyte
analysis, and receive the contaminated test medium into a separate
compartment for later disposal. This single compact device is designed to
mimic other common handheld devices such as a cellular phone, and can be
easily manipulated in a manner that follows a normal testing routine,
adding to a diabetic's flexibility in lifestyle, travel, convenience, and
comfort.

[0017] One object of the invention is to house the meter unit, an
electronic component that conducts the sample analysis. This object
receives user input, disposable test media, a battery to supply power,
and displays processed data results.

[0018] Another object embodies a mechanism that receives a disposable
lancet and can be moved between a set or ready position and a freed or
release position. This action is controlled by a firing button, armed
using a sliding access point, and generated by spring power. A removable
cap allows the lancet to be replaced and protects the lancet during
transport from accidents and contamination when not in use.

[0019] Another object consists of two air-tight enclosures, which store
used and unused disposable test media and or other material necessary for
operation such as disposable lancets, alcohol prep swabs, and a backup
battery.

[0020] Another object is to provide an enclosure for housing hypoglycemia
and or hyperglycemia treatment medication that is recommended to be
carried by diabetics at all times in order to treat emergency situations.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The above and other objects and advantages will become more
apparent upon consideration of the following drawings and detailed
description, in which:

[0022] FIG. 1A is a front perspective view of an embodiment of the present
invention with a meter unit positioned parallel and adjacent to a lancet
device.

[0023] FIG. 1B is a rear perspective view of an embodiment of the present
invention with a meter unit positioned parallel and adjacent to a lancet
device.

[0024] FIG. 2 is front perspective of an embodiment of the present
invention with a meter unit positioned parallel and adjacent to a lancet
device.

[0025]FIG. 3A is a front view of an embodiment of the present invention
with a meter unit positioned parallel and adjacent to a lancet device in
operation.

[0026] FIG. 3B is front view of an embodiment of the present invention
with a meter unit positioned parallel and adjacent to a lancet device
with hidden lines visible.

[0027]FIG. 4A is a perspective view of an enclosure for housing new test
media separately from soiled test media with one section lid open to
forty-five degrees, illustrating an exemplary manner of use.

[0028]FIG. 4B is a side view of an enclosure for housing new test media
separately from soiled test media.

[0029]FIG. 5A is a perspective view of an alternative embodiment of the
present invention, showing a detachable cartridge enclosure for housing
new test media separately from soiled test media.

[0031] FIG. 6A is a perspective view of an alternative embodiment of the
present invention with the meter unit positioned on top of the lancet
device, illustrating an exemplary manner of use for a sliding cover.

[0032] FIG. 6B is a rear perspective view of an alternative embodiment of
the present invention with the meter unit positioned on top of the lancet
device.

[0033]FIG. 7A is a perspective view of an alternative embodiment of the
present invention with an enclosure for housing hypoglycemia treatment
medication comprising a horizontal area.

[0034]FIG. 7B is a perspective view of an alternative embodiment of the
present invention with an enclosure for housing hypoglycemia treatment
medication comprising a vertical column area

[0035]FIG. 8A is a perspective view of the embodiment of the present
invention with a jacket, in an open state, surrounding the outside of the
apparatus.

[0036]FIG. 8B is a perspective view of the embodiment of the present
invention with a jacket, in a closed state, surrounding the outside of
the apparatus.

[0037] One embodiment of the present invention is illustrated in FIG. 1A
(front perspective view) and FIG. 1B (rear perspective view). The unit
can be constructed of any suitable material, but is preferably
constructed of an engineering plastic material. The front of the body of
the apparatus 6 is designed with an outside ridge that overlaps with the
back of the body 8 to allow for easy construction and a smooth outside
appearance. The design of these two pieces incorporate several openings
(in clockwise order around the apparatus): opening for test medium 12 to
be inserted, opening for firing button of lancet device 20, opening for
sliding button to arm lancet device 22, opening for buttons to control
meter 24, an opening for screen to cover meter LCD display 26, and an
opening for a battery, not shown. The corners and edges of the base are
designed with fillets to allow it to be comfortably held by a user's hand
and to be inserted and removed from a user's pocket with ease.

[0038] At the top right of the apparatus, a detachable cover for the
lancet device 18 is designed with a notch 14 and a post 15 that help to
hold the top in place. To remove the cover, a user pulls the cover
upwards as shown in FIG. 3A. A user may then remove or replace the lancet
110 that fits concentrically in the lancet body below. An opening in the
lancet device top 16 allows for the lancet to protrude from the device,
when the lancet device is armed and fired, so that it may puncture the
user's skin and produce a blood sample.

[0039] Another object of the present invention is a precision depth
control lancing tip, such as that described in U.S. Patent Application
20040127818, which is adjustable to control the amount of protrusion of
the lancet needle beyond the lancet device top opening. The purpose of
this adjustment is to control how large a blood sample is produced on a
patient's skin surface based on how far the needle penetrates the outer
skin membrane. Another purpose is to provide more comfortable testing
because increased levels of discomfort or pain are associated with deeper
levels of puncturing by the lancet needle.

[0040] Another object of the present invention is the enclosure for
housing new test media separately from soiled test media. The present
invention has a hollow storage space 42 that has been divided into two
spaces by a wall that connects to the top of the lid of the test media
enclosure 10 so that contaminates are prevented from entering the space.
The storage space comprises two areas, one that is to be used to store
new test media, and the other to be used to store soiled or used test
media. The spaces can also be used to store other materials chosen by the
patient, such as a spare battery for the meter unit, spare lancets,
alcohol prep swabs, or other medication.

[0041] The enclosure is a self-contained space with walls on all sides,
because the storage for unused test strips must be air-tight and possibly
accommodate a humidity removing lining such as that described in U.S.
Pat. No. 5,911,937. Some test strips that are exposed to air or a
non-humidity controlled environment will be damaged, unusable, or
unreliable, producing erroneous results if used to conduct blood glucose
testing.

[0042] FIG. 4 shows additional details of a test media enclosure with a
hinge on the lid of the test media enclosure 44 constructed from any
suitable material, preferably an engineering plastic material, and a
recessed groove on the lid 46 to allow for the user to open the storage
compartment and insert/remove test strips. The notch lock on the lid 40
is just one example of a component to hold the lid in the closed position
and maintain air-tightness.

[0043] A hinge on the lid of the test media enclosure 44 is only necessary
to assist the lid from being disconnected and misplaced by the user.
Another embodiment has no hinge and a removable lid. Another embodiment
allows the lid to slide off the surface of the storage space, in a
fashion similar to that of the sliding detachable lancet cover 50 shown
in an alternative embodiment of the apparatus FIG. 6A. In the embodiment,
a locking mechanism is created by a lid covering the entire side of the
body of the apparatus, fitting into grooves, and sliding parallel to the
device in a manner than can used to produce access to the container
contents below. The lid can also be created to slide in any direction or
to provide access to only one compartment of the enclosure for housing
test media at a time.

[0044] The lids used to cover the test media enclosure can comprise two
lids to cover each section as shown in FIG. 4A or one lid to cover both
sections as shown in FIG. 5A. Preference is given to one lid in order to
simplify manufacturing.

[0045] The recessed groove on the lid 46 is given preference for enabling
the lid to be disengaged and opened, but is just one embodiment. There
are several recessed area configurations such as a circular indentation
on the lid with grooves that allow a user's finger to apply force and
open the enclosure. Another embodiment is to use an extended tab like
that shown in the tab for assisting opening 56 of the enclosure for
housing hypoglycemia treatment medication shown in the alternative
embodiment of the apparatus in FIG. 7A.

[0046] There are many possibilities and arrangements to keep the container
as airtight and free from contamination as possible. An alternative
embodiment is shown in FIG. 5A, which has protruding walls on all four
sides of the lid. Each protruding wall has a notch that overlaps with the
lid's notch to keep the enclosure closed. This overlapping notched lock
design can be seen in FIG. 4B. The alternative design in 5A includes
rounded corners to allow for the lid to close more smoothly and to
prevent weak points from developing at corner wall intersections. Another
embodiment is a design that utilizes an elliptical locking opening in the
lid that fits into elliptically arranged protruding walls. The lid and
wall arrangement can also be reversed wherein the lid has a protrusion
that fits inside of the walls of the storage space.

[0047] The goal for the test media enclosure is to optimize the area for
storage of test media and to be robust for withstanding repeated use. The
design presented in FIG. 5A and 5B shows the enclosure as a detachable
cartridge with a notched locking mechanism 48. The purpose of the test
media enclosure being detachable is to overcome design and material
robustness concerns by providing the enclosure as replaceable. Another
purpose is to replace the test media enclosure if the hollow storage
space becomes dirty from use. Another purpose is to allow new test media
to be distributed to patients in a convenient container.

[0048] The notched locking mechanism 48 is just one possible method for
securing the cartridge between the front and back surfaces of the
apparatus body. The notches are located on the side of the cartridge and
snap the cartridge into position for operation. The cartridge can be
removed by forcibly pulling the cartridge outwards away from the
apparatus body. The outside surface of the cartridge can be altered with
different materials, such as a foam or adhesive, in order to create
additional positive friction that can be used to hold the cartridge in
place. Another embodiment is a locking mechanism that attaches to the
bottom of the cartridge body and locks into a receptacle inside the
apparatus.

[0049] There are many possibilities and methods for the present invention
to embody the position and attachment of the enclosure for housing test
media and to allow the lid opening to lock and create an air-tight seal.
In one embodiment, the storage area is located completely on the rear of
the apparatus, instead of between the top and bottom base layers, with
lids for accessing the interior of the enclosure that can be positioned
on any side. This storage area is added completely onto the rear of the
device in a new space. In another embodiment a similar storage space is
removable and attaches by snapping onto the back of the apparatus,
meeting the above mentioned goals of an enclosure for housing test media
that is detachable. In another embodiment, a lid opens a portion or the
entire rear of the apparatus, uncovering a storage area that is created
from the free space available around the main device components. In
another embodiment, this free space storage area is accessed via the
front, bottom, or top of the device.

[0050] The direction for opening the lid of the test media enclosure may
be constructed in either a rear opening configuration, as demonstrated in
FIG. 4B, or a forward opening configuration, as shown in FIG. 5A.
Preference is given to a forward opening configuration in order to allow
the lid to serve as a platter and prevent the compartment contents from
falling out. With the meter LCD display facing the user, the rear opening
configuration assists opening by a patient's forefingers, while a forward
opening configuration assists opening by a patient's thumb, for
right-handed patients.

[0051] Another feature of the enclosure for housing test media is a size
appropriate to the height of a test strip in order to eliminate excessive
space that contributes to rattling of test strip contents and noisy
transportation. The hollow storage space 42 in the present invention is
only slightly deeper than the height of test media. The width of the
compartment opening is also of a specific size as to allow the test media
only to be stored vertically within the enclosure, preventing test strips
from falling into a horizontal position is difficult for the patient to
retrieve or extract strips from the bottom of the compartment. For an
idea of the shape and size of test medium relative to the present
invention, refer to test strip 112 shown in FIG. 3A.

[0052] An alternative embodiment to apparatus of the present invention has
a larger, general purpose storage compartment that can be used to hold
additional spare lancet needles or individually packaged alcohol prep
swabs, used to clean and disinfect a user's skin at the site a user
wishes to use for producing a blood sample.

[0053] The blood glucose meter receives a test strip 112 via the opening
for test media 12. The blood glucose meter further comprises a display
window 26, such as an LCD display or like device, which can display any
number of test results. A plurality of blood glucose meter operation
buttons 24 or controls can be provided to allow a user to control the
meter and meter display window. A data connector can be provided with the
blood glucose meter 32 for communication access, such as to upload data
from other devices or to download data from the device to other devices.
The data connector can be disposed on the bottom of the apparatus body
and can comprise any number of hardwired or wireless communication
connectors.

[0054] The blood glucose meter also includes a memory for storing measured
blood glucose values, exercises and meals, along with other related data
such as corresponding dates, time of day, and duration of each, and the
units that were used as these values and events were measured. The meter
can also host software that can be programmed to offer the user advice
and alerts according to blood glucose patterns and trends.

[0055] In order to use the apparatus of the present invention, the patient
must first remove the lancet device top 18 by pulling it straight away
from the body of the apparatus. Next, the patient inserts a lancet 110
into the lancet device by placing it concentrically into the opening of
the body of the lancet device and placing it forcibly downwards. Next,
the patient replaces the lancet device top and removes a test strip by
using the recessed groove on the storage container lid to open the
storage container. The patient then takes the test strip 112 and inserts
it into the opening for test media 12 at the top of the unit.

[0056] The device should then be rotated onto its side, so that it is
perpendicular to the patient's finger from which the blood sample will be
drawn. For example, the apparatus should be held with the left hand while
it is placed against the pad of the patient's right hand index finger.
Next, the button to arm the lancet device 22 is slid backwards until the
lancet device locks behind the firing button for the lancet device 20.
The firing button can then be pressed with a thumb or free finger,
causing the lancet to project rapidly forward, penetrating the opening in
the lancet device top 16 and the user's finger. The user can then
reposition their finger on the adjacent test medium, transferring the
fresh blood sample. When the meter LCD screen displays the results for
the test, the test medium can be removed from the test meter and placed
into the test media enclosure for soiled test media.

[0057] When the enclosure for new test strips becomes empty it can be
refilled and when the enclosure for soiled test strips becomes full it
can be emptied into an appropriate waste receptacle. The present size of
the enclosure for housing test media of the present invention allows for
approximately 30-40 test strips to be stored in each of the two
compartments. This supply can last a diabetic who tests 5 times a day for
approximately one week's duration. Lancet needles can typically last a
long time and users will tend to replace these based on their personal
preference or when the lancet becomes painful to use, indicating the
needle has dulled. The common durations for replacing lancet needles can
range from every 2 days to every 2 months to every 21 tests.

[0058] Placing used test strips in the used test strips compartment of the
enclosure for housing test media will over time cause the compartment to
become dirty from dried human blood. While this does not cause damage to
the operation of the present invention, the compartment can be cleaned
and sanitized.

[0059] Another embodiment to aid in cleaning of the used test strip
compartment uses a smooth contoured design, without edges, for the bottom
of the storage space of the enclosure for housing test media.

[0060] An insertable disposable plastic lining, film, or container that
fits within the storage space of the enclosure for housing test media is
another embodiment of the present invention that can be used to protect
the enclosure if it is not replaceable. It can also be used as a method
to distribute and replace new test strips into the new test strip
compartment.

[0061] There are various possibilities for attaching and combining the
lancet device with the main meter and storage compartment while still
maintaining a discrete shape to the apparatus. Having the lancet device
be detachable from the body of the apparatus in the present invention
also has advantages in allowing the patient greater access to testing
sites, potentially on arm, palm, and thigh, although testing on finger
tips is preferably for producing the most accurate and current blood
glucose measurements.

[0062] In another embodiment, the apparatus of the present invention
allows the lancet device to detach from the test meter and test media
enclosure. In the embodiment, the rectangular shaped lancet device uses a
similar style notch as used for the lancet device top 14, which continues
along the side of the entire lancet device assembly. This allows the
lancet device to slide parallel against the meter until the two become
separated. When the two are in the attached position, the outside
appearance of the device appears smooth and unbroken.

[0063] In another embodiment the apparatus of the present invention has a
pivotable center point, connecting the lancet device and the main meter
body and allowing the lancet device to spin 360 degrees around the center
pivot. This allows for increased freedom in positioning the lancet device
to access testing sites without the test strip interfering. This pivot
point can be placed at any position on the lancet device body and can
also allow the lancet device to become fully detached via the pivot
point.

[0064] FIG. 6A and 6B present an alternative embodiment in which the
lancet device is constructed beneath the meter and accessed from the back
of the apparatus. This design creates a simpler configuration and
appearance for the front of the invention that increases the ability of
the device to resemble other common portable electronic devices. Concern
for this arrangement is given to creating an apparatus that is too thick.
The opening used to insert the lancet into the lancet body is located
beneath a sliding detachable cover 50. In the embodiment, the lancet
device is operated by controls positioned on the back of the apparatus.

[0065] Another embodiment of the apparatus of the present invention has
the ability to carry a patient's medication to treat hypoglycemia, often
in the form of glucose tablets. Diabetics, particularly type I diabetics,
must carry glucose tablets or some form of treatment for hypoglycemia, at
all times. If a diabetic does not treat hypoglycemia quickly and
efficiently he or she risks substantial harm and possibly death. Other
effective methods for treating hypoglycemia include: injection of
glucagon, high glucose gels or pastes, and ingestion of high glucose
containing food such as soft drinks or fruit juice. Preference is given
to the use of glucose tablets because they are compact, easily
transportable, and affordable.

[0066] Current methods for portably and compactly carrying glucose tablets
are few as glucose tablets are typically distributed in containers
holding large quantities. Preferred transportable methods are
individually wrapped glucose tablets or a refillable small plastic tube
that can carry stacked glucose tablets, having a detachable cover on one
end.

[0067] FIGS. 7A and 7B present additional embodiments of the apparatus of
the present invention, having an enclosure with a designated storage
space for housing glucose tablets or other medication for the treatment
of hypoglycemia. In FIG. 7A, the medication is stored vertically in a
column like fashion with a hinged lid at the opening in the bottom of the
apparatus for removing the medication. The vertical column space can also
house a tube of glucose gel or paste medication and a glucagon syringe
kit. In FIG. 7B the storage space for the medication comprises a
horizontal area at the bottom of the apparatus.

[0068] In both cases, the housing is air-tight similar to the enclosure
for housing test media, in order to prevent spoiling of the medication
from exposure to air or other contaminants and to prevent leakage of the
enclosure contents. The housings also open in directions opposite of the
lancet device and opening for test media in order to prevent medication
from contaminating blood glucose testing operation and from influencing
test results. In alternative embodiments of the present invention, the
enclosure is placed in positions on the back and sides of the apparatus.

[0069] Glucose tablets come in various sizes and the housing for
hypoglycemia medication can be made in different sizes to accommodate
variations. Concern is given to keeping the apparatus as compact as
possible. The present invention can store enough glucose tablet
medication for several treatments. Recommended treatment dose for glucose
tablets is 3-4 tablets per hypoglycemic episode, but can vary depending
on severity of hypoglycemia and patient intuition.

[0070] Another embodiment of the apparatus of the present invention is the
ability to carry medication to treat hyperglycemia, often in the form of
an insulin vial and syringe. In this embodiment the vial and syringe are
stored in a vertical column or at the bottom of the apparatus, similar to
the embodiment used for carrying hypoglycemia treatment medication. The
vial can be stored in a location on the device different from the
location of the syringe. Concern is given to the size of the apparatus of
the present invention when it includes a treatment for hypoglycemia and
hyperglycemia. Because treatment for hyperglycemia is not as urgent as
that for hypoglycemia, preference is given to an apparatus with an
enclosure for housing hypoglycemia medication prior to hyperglycemia.
This preference is based on the constrained size and space requirements
to maintain the present invention's ability to fit into a user's pocket
on his or her clothing.

[0071] An additional embodiment for a cover or jacket to surround the
outside of the device is presented in FIG. 7. The purpose of this jacket
is to offer additional protection for the device against damage,
contamination, or accidental operation, and to create an inconspicuous
outer appearance for the apparatus. Alternative embodiments for this
cover, or jacket are possible.

[0072] From the descriptions above, a number of advantages of some
embodiments of the self-contained diabetic testing apparatus of the
present invention become evident:

[0073] (a) There is no clutter of
having to carry test meter, lancet, and test strip container separately.

[0074] (b) The apparatus is compact and can easily fit in a user's pants
pocket.

[0075] (c) The apparatus can be manipulated quickly and easily,
allowing for a predictable testing routine and fast execution of testing
procedures.

[0076] (d) The unit is simple and discrete. It does not draw
unwanted attention.

[0077] (e) There is a separate compartment for
storage of used test media, allowing the media to be disposed of when
convenient.

[0078] (f) The enclosure for housing test media can be
detached and replaced to re-supply test media and replace dirty
enclosures.

[0079] (g) Hypoglycemia or hyperglycemia medication is
immediately available and accessible to the patient upon confirmation of
blood glucose test result.

[0080] Accordingly, it will be understood that the self-contained blood
glucose testing apparatus of the present invention can be used easily and
conveniently and carried in a user's pocket, having tremendous impact on
diabetics who must currently carry a purse, backpack, hip-pack, or other
bag to transport their testing equipment in daily life.

[0081] Furthermore, it allows a diabetic patient the ability to carry the
meter with him or herself at all times, so that they are not stuck in a
dangerous situation where they need the ability to test blood sugar but
did not bring the meter because they did not want to carry an extra bag.
Common examples of such situations include, but are not limited to,
exercising, walking, biking, going out with friends, shopping in a store
and leaving the meter in the car, etc.

[0082] Additionally, because many test meters and test media are very
sensitive to fluctuations in temperature, keeping the test meter with the
user is the best way to avoid damage to the unit and avoid periods of
inaccurate results or operation failure. When a meter is left behind in a
locked car, the temperature can quickly rise or descend depending on
weather and time of year. When the diabetic user returns to the car to
use the device before operating the vehicle, they must act to heat or
cool the device in order for it to work correctly or work at all. This
usually involves waiting for some time and can create an uncomfortable or
dangerous situation for the patient who is unable to accurately rely on
his or her blood glucose meter or perform blood glucose analysis. The
present invention will dramatically reduce a diabetic's exposure to
unnecessary risk and stress, while simultaneously increasing their
flexibility with the goal of providing them with as comfortable and
normal of a life as possible.

[0083] In addition, the apparatus optimizes the flow of a blood glucose
testing routine making the unavoidable task of testing blood glucose
concentration quicker and simpler. Tedious manipulation of each component
individually is greatly reduced by the invention.

[0084] The apparatus also aids in helping an individual who needs to check
their blood sugar in a public setting to more readily conceal the fact
that they have diabetes. Because the apparatus resembles a cellular phone
or other small electronic device, the user appears to simply be checking
the status of some common electronic gadget when using the meter, instead
of performing a serious medical test involving lancing the skin with a
sharp needle to produce an exposed blood sample. The flow and layout of
the components for the apparatus also increase the speed at which a blood
glucose test can be conducted, so that a user can finish the test in a
few seconds and minimise his or her exposure to unwanted attention and
intrusion by others.

[0085] Although the descriptions above contain many specificities, these
should not be construed as limiting the scope of the embodiments, but as
merely providing illustrations of some of the presently preferred
embodiments. For example, the apparatus can have other shapes and sizes
and the meter, lancet device, and storage compartment can be configured
in different arrangements. Thus the scope of the embodiments should be
determined by the appended claims and their legal equivalents, rather
than by the examples given.